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Идёт набор NCT06948487

Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

Наблюдательное Gastritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gastritis. Базовые параметры: 19 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Prospective, Multi-center, Observational Study on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

Обзор

This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.

Подробное описание

In this observational study, patient-reported data will be collected using an electronic application (e-PRO). The survey on subjective symptoms will be administered twice-once before and once after the administration of Fexuclue tablets. Additionally, a survey on medication convenience will be conducted once at 2 weeks (up to a maximum of 4 weeks) post-administration.

At the same time point (2 to 4 weeks after administration), patients will self-assess their overall improvement through the e-PRO application. Investigators will also evaluate final improvement based on clinical judgment in a real-world setting and record the outcome in the Case Report Form (CRF).

Первичные конечные точки

  • The proportion of subjects with improvement in subjective symptoms [Срок оценки: 2 weeks(up to 4 weeks)]
Вторичные конечные точки (5)
  • Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily) [Срок оценки: 2 weeks(up to 4 weeks)]
  • Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe) [Срок оценки: 2 weeks(up to 4 weeks)]
  • Disappearance rate of subjective symptoms [Срок оценки: 2 weeks(up to 4 weeks)]
  • Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened' [Срок оценки: 2 weeks(up to 4 weeks)]
  • Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient' [Срок оценки: 2 weeks(up to 4 weeks)]

Критерии участия

Критерии включения

  • Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent.
  • Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication.
  • Subjects who present with at least one subjective symptom requiring medical treatment
  • Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.

Критерии исключения

  • Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling.
  • Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

South Korea · 1 центр
  • Masong Kim Internal Medicine Clinic — Seoul

Идентификаторы

NCT: NCT06948487 · DW_FEX_DB_03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗